fNIRS for CI mapping in patients with malformations

JRCT ID: jRCTs052200030

Registered date:25/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: bilateral severe sensorineural hearing loss
• Date of first enrollment: 30/07/2020
• Target sample size: 40
• Study type: Interventional
• Intervention(s): to determine parameters of electrical stimuli by the cochlear implant on the basis of results of fNIRS measurements in cochlear implant users with inner ear malformations

Outcome(s)

• Primary Outcome: Percentages of electrodes which successfully detect cochlear implant-induced neural responses

Secondary Outcome

(1) duration of EABR and fNIRS measurements
(2) thresholds determined by EABR, fNIRS, and behavioral measurements
(3) adverse effects, diseases, and equipment troubles

Key inclusion & exclusion criteria

• Age minimum: >= 10month old
• Age maximum: < 18age old
• Gender: Both

Include criteria

(1) patients having inner ear or internal auditory canal (IAC) malformations and diagnosed as severe or profound hearing loss
(2) age at testing ranges from 10 months old to 18 years old
(3) patients who underwent cochlear implantation
(4) patients who have signed to a written consent-form

Exclude criteria

(1) patients who can not keep standing still for 3 minutes
(2) patients who have severe dermatitis or infection on the head skin
(3) patients who the principal investigator or research collaborators have decided to be inappropriate as the participants

Related Information

• Primary Sponsor: Yamazaki Hiroshi